Prolapse repair

ABSTRACT

Surgical instruments for prolapse repair are disclosed. The surgical instruments have straight portions and helical portions.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. Provisional PatentApplication Nos. 60/504,755, filed Sep. 22, 2003 and 60/545,987 filedFeb. 19, 2004 (the entire contents incorporated by reference herein).

BACKGROUND

There are a wide variety of surgical techniques used to repair vaginalprolapse and apical defects. There is no consensus supporting theefficacy of one technique over the others.

Surgical approaches vary. They include vaginal, abdominal andlaparoscopic surgical approaches. See Richter K: Massive Eversion of theVagina: Pathogenesis, Diagnosis and Therapy of the True Prolapse of theVaginal Stump, Clin. Obstet Gynecol 25:897-912 (1982); Diana et al.,Treatment of Vaginal Vault Prolapse with Abdominal Sacral ColpopexyUsing Prolene Mesh, American Journal of Surgery, Vol. 179, (February2000), Pps. 126-128; Winters et al., Abdominal Sacral Colpopexy andAbdominal Enterocele Repair in the Management of Vaginal Vault Prolapse,Urology 56 (Suppl 6A) (2000): 55-63; and Paraiso et al, LaparoscopicSurgery for Enterocele, Vaginal Apex Prolapse and Rectocele, IntUrogynecol J (1999), 10:223-229.

Abdominal sacral colpopexy is considered to be an especially efficacioustreatment, but it has been criticized for its inability to addressposterior wall defects or perineal descent problems. This can result inpersistent or altered defactory issues. See Bassler et al., AbdominalSacrocolpopexy and Anatomy and Function of the Posterior Compartment,Obstet. Gyn 2001; 97:678-683. These procedures are generally consideredinvasive.

Sacrospinous ligament suspensions are also popular. However, theseprocedures have been criticized for distorting support symmetry aboutthe vaginal axis. This could contribute to a predisposition for futuredefects in the anterior compartment. See Paraiso et al., Pelvic supportdefects and visceral and sexual function in women treated withsacrospinous ligament suspension and pelvic reconstruction. Am J ObstetGyn 1996; 175:1423-1431. See also, Guner et al., TransvaginalSacrospinous Colpopexy For Marked Uterovaginal and Vault Prolapse,Inter. J. of Gynec. & Obstetrics, 74 (2001) Pps. 165-170. This fixationis believed to risk complications through damage to the pudendalneurovascular bundle and sciatic nerve. Uterosacral ligament suspensionis another repair procedure, but risk of ureteral injury still exists.

PCT Publication No. WO 00/64370 (Gaston) describes a device for treatinga prolapse by vaginal suspension. The device comprises an elongate,flexible, pierced material, a suture connected to the material and asuture needle joined to the suture. The device is long enough to enableposterior suspension of the vagina at the promontory (i.e. the frontupper part of the sacrum). The other end of the device includes a distalportion having a width such that it can cover at least a large part ofthe posterior part of the vagina, a rounded cut-out with dimensions thatenable it to be engaged around the base of the vagina on at least alarge part of the lower half of the wall of the vagina. The suture isconnected to the article so that it is offset sidewise in relation tothe cut-out.

PCT Publication No. WO 00/27304 (ORY et al.) discloses a suspensiondevice for treating prolapse and urinary incontinence. The devicecomprises at least one filiform suspension cord with limited elasticityand at least two anchoring parts linked to the ends of the cord.

PCT Publication No. Wo 02/078552-A1 discloses an apparatus for treatingvaginal vault disorders.

Published U.S. Pat. Appl. Nos. 2003/0220538-A1 and 2003/0176762 purportto disclose surgical instruments for treating prolapse.

U.S. Pat. No. 5,112,344 and PCT Publication No. PCT/US02/32284 disclosesurgical devices for female pelvic health procedures. The IVS Tunnellerdevice is available from U.S. Surgical of Norwalk, Conn. The IVS devicecomprises a fixed delta wing handle, a hollow metal tube and a styletthat is placeable within the tube. The stylet has a rounded plastic tipon one end and an eyelet at the other end. The device may be used toimplant a polypropylene tape for infracoccygeal sacropexy and othersurgical procedures. See Farnsworth, Posterior Intravaginal Slingplasty(Infracoccygeal Sacropexy) For Severe Posthysterectony Vaginal VaultProlapse—A Preliminary Report on Safety and Efficacy, Int. Urogynecol.J. (2002) 13:4-8; Petros, Vault Prolapse II: Restoration of DynamicVaginal Supports by Infracoccygeal Sacropexy, an Axial Day-Case VaginalProcedure, Int Urogynecol J (2001) 12:296-303; and Petros, TheIntravaginal Slingplasty Operation, a Minimally Invasive Technique forCure of Urinary Incontinence in the Female, Aust. NZ J Obstet Gynaecol,(1996); 36: 4:453.

A single, rigid, hollow metal tube is associated with the IVS Tunnellerdevice. This single tube passes through two separate regions of thepatient's body with the attendant risk of cross contamination. The outerdiameter of the tube is also relatively large (about 0.25 inches) withthe attendant risk of tissue damage due to a large diameter needle.

The polypropylene tape supplied with the IVS Tunneller is a thin,rectangular shape, believed to be approximately 8 mm×350 mm. The thin,rectangular tape supplied with the IVS Tunneller is not believed to beextensible. Under a longitudinal force, the implant is highly resistantto elongation. It is believed that inextensible polypropylene tapes maybe apt to exhibit a greater association with erosion and failure.

A recent abstract describes using a 15×14 cm implant, placedtransvaginally, to repair the anterior, median perineal defect. SeeMouly et al., Vaginal Reconstruction of a Complete Vaginal Prolapse: TheTrans Obturator Repair, Journal of Urology, April 2003, Vol 169 (4)supplement, p 183, Abstract # V 702, AUA Apr. 26-May 1, 2003, Chicago,Ill. The abstract also discloses that wings of the mesh are insertedthrough the obturator holes. Another publication describes an anteriorwall repair. See Salomon et al., Treatment of Anterior Vaginal WallProlapse with Porcine Skin Collagen Implant by the Transobturator Route:Preliminary Results; European Urology 45 (2004), 219-245. This procedureutilizes an Emmet needle to pierce the obturator foramen.

BRIEF SUMMARY

The present invention is directed to novel surgical instruments forsurgical procedures that treat prolapse. Novel surgical procedures thatutilize such instruments are also disclosed.

In one aspect, the present invention comprises a surgical instrument forinserting an implant for treating female prolapse. The surgicalinstrument comprises a handle and a needle portion. The needle portionhas a straight portion emerging from the handle and a generally helicalportion having a distal end region. The needle portion is sized andshaped so that the distal end region may initially be moved through apatient's obturator foramen toward the region of the patient's ischialspine, and then toward a vaginal incision in the region of the vaginalapex, so that an implant may be received by the distal end of the needleand moved from the vaginal incision through the patient's obturatorforamen.

The helical portion may comprise either a left or a right handed helicalportion. Preferably, the needle portion has a generally circular crosssection with a diameter of less than about 5.5 mm and more than about0.5 mm. In a preferred embodiment, the straight portion of theinstrument has a longitudinal axis and the helical portion has a length,measured along the longitudinal axis of the straight portion, of morethan 2 inches and less than twelve inches. In the preferred embodiment,the helical portion has a width of more than about 1 inch and less thanabout 9 inches. Preferably, the helical portion has a pitch of at least2 inches and less than seven inches and a radius of at least 0.5 inchesand less than four inches.

In a preferred embodiment, the straight portion of the instrument has alongitudinal axis and the helical portion has an axis that is notparallel to the axis of the straight portion. The axis of the straightportion and the axis of the helical portion form an angle, preferably ofabout 8 degrees. The distal end portion of the instrument points awayfrom the handle and at an acute angle relative to a plane that isperpendicular to the longitudinal axis of the straight portion of theinstrument.

In another aspect, the present invention comprises an assembly ofsurgical instruments for treating female prolapse. The assemblycomprises a first surgical instrument comprising a handle; a needleportion having a straight portion emerging from the handle and agenerally right handed helical portion having a distal end region. Theneedle portion is sized and shaped so that the distal end region mayinitially be moved through a patient's obturator foramen toward theregion of the patient's ischial spine, and then toward a vaginalincision in the region of the vaginal apex. The assembly includes asecond surgical instrument comprising a handle; a needle portion havinga straight portion emerging from the handle and a generally left handedhelical portion having a distal end region. The needle portion of thesecond needle is sized and shaped so that the distal end region mayinitially be moved through a patient's obturator foramen toward theregion of the patient's ischial spine, and then toward a vaginalincision in the region of the vaginal apex. The assembly also includesan implant for treating the prolapse.

In a preferred embodiment, the assembly may include a pair of dilatingconnectors and insertion sleeves surrounding the implant. Alternativelythe distal end portions of the needles may include eyelets. The implantmay be extensible or inextensible. Preferably, an insertion sleeveaccompanies an extensible implant.

A surgical procedure is also described. The surgical procedure caninclude the steps of: i) providing a first surgical instrumentcomprising a handle, a needle portion having a straight portion emergingfrom the handle and a generally right handed helical portion having adistal end region; a second surgical instrument comprising a handle, aneedle portion having a straight portion emerging from the handle and agenerally left handed helical portion having a distal end region; ii)creating a vaginal incision; iii) incising the patient's skin in theregion of the patient's obturator foramen on a first side of thepatient, iv) passing the distal end portion of the first surgicalinstrument through the obturator foramen and then through the vaginalincision; v) associating the implant with the first surgical instrument;vi) incising the patient's skin in the region of the patient's obturatorforamen on a second side of the patient, vii) passing the distal endportion of the second surgical instrument through the obturator foramenand then through the vaginal incision; viii) associating the implantwith the second surgical instrument; ix) moving the distal end portionof the first surgical instrument from the vaginal incision through thepatient's obturator foramen with an end of the implant associated withthe distal end portion; x) moving the distal end portion of the secondsurgical instrument from the vaginal incision through the patient'sobturator foramen with an end of the implant associated with the distalend portion; and xi) attaching the implant to the vagina. Preferably,the step of creating a vaginal incision includes the step of creating avaginal incision in a region of the apex of the vagina. Also preferably,the step of passing the distal end portion of the first surgicalinstrument through the obturator foramen and then through the vaginalincision includes the step of passing the distal end of the instrumentthrough the inferior part of the obturator membrane in the region of theobturator foramen above the ischio-pubic ramus.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will be seen asthe following description of particular embodiments progresses inconjunction with the drawings, in which:

FIG. 1 is a top view of a surgical instrument showing an axis for ahelical portion of the instrument;

FIG. 1A is another view of the surgical instrument of FIG. 1;

FIG. 2 is an end view of the surgical instrument of FIG. 1, taken in aplane substantially perpendicular to the axis of the helical portion ofthe instrument;

FIG. 2A is a view of the instrument of FIG. 1 taken in a planesubstantially perpendicular to the axis of a straight portion of theinstrument;

FIG. 3 is another view of the instrument of FIG. 1;

FIG. 3A is another view of the instrument of FIG. 1;

FIG. 4 is a top view of a surgical instrument showing an axis for ahelical portion of the instrument;

FIG. 4A is another view of the surgical instrument of FIG. 4;

FIG. 5 is an end view of the surgical instrument of FIG. 4, taken in aplane substantially perpendicular to the axis of the helical portion ofthe instrument;

FIG. 5A is a view of the instrument of FIG. 4 taken in a planesubstantially perpendicular to the axis of a straight portion of theinstrument;

FIG. 6 is another view of the instrument of FIG. 4;

FIG. 6A is another view of the instrument of FIG. 4;

FIG. 7 is a schematic view of portions of a human female pelvic region,showing a prolapsed vagina;

FIG. 8 is a perspective view of an assembly of surgical articles for usein a subsequent procedure for treating prolapse;

FIGS. 9 through 22 schematically illustrate the use of the assembly ofsurgical articles of FIG. 8 in treating prolapse, wherein:

FIG. 9 shows a surgical instrument just as it begins to traverse thepatient's right obturator foramen;

FIG. 10 illustrates the distal end portion of a surgical instrumentafter it has traversed the obturator foramen and while it is being movedin the general direction of the ischial spine;

FIG. 11 illustrates the distal end portion of the surgical instrument asit is being moved toward a vaginal incision and a surgeon's finger;

FIG. 12 illustrates the surgical needle after the distal end region hasentered the vaginal vault;

FIG. 13 illustrates a connecting dilator and a portion of an implantassembly as the connecting dilator is being moved toward the distal endregion of the surgical instrument;

FIG. 14 illustrates the connecting dilator after it has been connectedto the distal end region of the surgical instrument;

FIG. 15 illustrates the implant assembly after one end portion has beenguided by the surgical instrument through a vaginal incision, throughtissue and then toward an incision adjacent the obturator foramen;

FIG. 16 illustrates the end portion of the implant assembly after it hastraversed the obturator foramen and emerged from a skin incision;

FIG. 17 illustrates a scissors after it has separated the surgicalinstrument and dilating connector from the remaining portion of theimplant assembly;

FIG. 18 illustrates a second surgical instrument after it has passedthrough the patient's left obturator foramen, and after the distal endregion of the surgical instrument has emerged through a vaginalincision, which figure also illustrates a second dilating connectorattached to the distal end region of the second needle;

FIG. 19 illustrates the implant assembly after the surgical instrumenthas guided the dilating connector through the patient's left obturatorforamen;

FIG. 20 illustrates a surgical scissors being used to separate thedilating connector (with attached surgical instrument) from the rest ofthe implant assembly;

FIG. 20A illustrates the implant attached (e.g. stitched) to the vaginain the region of the apex;

FIG. 21 illustrates insertion sheaths of the implant assembly beingremoved from the body; and

FIG. 22 illustrates the implant that corrects the vaginal prolapse justprior to it being trimmed to the skin incisions adjacent the patient'sobturator foramen.

DETAILED DESCRIPTION

The following description is meant to be illustrative only and notlimiting. Other embodiments of this invention will be apparent to thoseof ordinary skill in the art in view of this description.

FIGS. 1-3A illustrate a surgical instrument for use on one side of thepatient's body. FIGS. 4-6A disclose a surgical instrument for use on theopposite side of the patient's body.

The surgical instrument 10 includes a straight portion 12, a helicalportion 14, and a distal end region 15. Similarly, the surgicalinstrument 20 includes a straight portion 22, a helical portion 24, anda distal end region 25. Preferably, the surgical instruments 10 and 20include handles 11 and 21 (FIG. 8) which are not shown in FIGS. 1-6A.

The surgical instruments 10 and 20 are adapted for a surgical procedurefor reconstruction of the vaginal vault, as described more fully below.The cross sectional shape of the straight and helical portions can be ofa wide variety of shapes and is preferably small. For a circular crosssection, the diameter is preferably less than about 5.5 mm and more thanabout 0.5 mm.

As an example, not intended to be limiting, the surgical instrument 10may have a diameter of 0.125 inches. The length L1′ is preferably morethan about 5 inches and may be about 6 inches, the length L2′ ispreferably more than 1 inch, more preferably more than 2 inches and evenmore preferably about 2.76 inches. The length L1′ is preferably lessthan twelve (12) inches. The width W′ is preferably more than one inchand less than about 9 inches. In a preferred embodiment the width W′ maybe about 2.15 inches. Preferably about two inches of the straightportion 12 project from the end of the handle 11. The helical portion 14preferably has a radius of at least 0.5 inches, more preferably 0.825inches and a pitch of at least about 2 inches preferably about 3.65inches. The surgical instrument may be formed about a mandrel with adiameter of 1.5 inches and a groove (for receiving the surgicalinstrument) with a pitch of 3 inches. Notably, the axis A′ of thehelical portion 14 is offset from the longitudinal axis of the straightportion 12 (see FIGS. 1 and 3). In this embodiment, the offset is about8 degrees. In a preferred embodiment, the offset for both instruments 10and 20 is the same and at least 5 degrees. The bend between the straightand helical portions 12 and 14 may have a radius of about 0.3 inches.

Preferably, the distal end portion 15 of the surgical instrument pointsaway from the handle 11 (FIG. 8) and at an acute angle relative to aplane that is perpendicular to the longitudinal axis of the straightportion 12 of the instrument.

Similarly, for instrument 20, length L1 may be about 6 inches, thelength L2 is about 2.76 inches, and width W of about 2.15 inches.Preferably about two inches of the straight portion 22 project from theend of the handle 21. Again, the axis A of the helical portion 24 isoffset from the longitudinal axis of the straight portion 22. Thehelical portion 24 preferably has a radius of 0.825 inches and a pitchof about 3.65 inches. The ranges for the size and shape of theinstrument 20 are the same as described above for the instrument 10.

One of the helical portions 14 and 24 has a right hand helix and theother has a left hand helix. The surgical instruments 10 and 20 may beconstructed from any suitable polymeric or metallic material. Onesuitable material is stainless steel 17-4 PH hardened to H900.

FIG. 8 shows an assembly of surgical articles 10, 20 and 30 for treatingprolapse. The assembly preferably includes surgical articles 10 and 20and an implant assembly 30 with dilating connectors 35, implant 34 andseparable insertion sheath 32. The dilators and insertions sheath areoptional. Alternatively, for example, the distal end portions of thesurgical instruments 10 and 20 may include eyelets for receiving theimplant 34.

The distal end regions 15 and 25 may have surfaces that are speciallyshaped to engage complementary surfaces on the dilating connectors 35 ofan implant assembly 30. Such assemblies are disclosed in published U.S.Pat. Application Nos. 2003/0171644-A1 and 2003/0176875-A1.

The implant assemblies 30 typically include an implantable material 34that remains in the body. The implantable material may comprisesynthetic or non-synthetic materials or hybrids, composites orcombinations thereof.

A synthetic material is preferable. Suitably synthetic materials includepolymerics, and plastics and any combination of such materials.Commercial examples of such materials include Mersile™, Teflon™,Gore-Tex™, Silastic™, Marlex™, Prolene™, and Vaskutek™. Other examplesof suitable materials include those disclosed in U.S. Pat. No.6,652,450. Specific examples of synthetic sling materials includeabsorbable and non-absorbable materials such as polypropylene,polyethylene, nylon, PLLA and PGA. Additional meshes are disclosed inDietz et al., Mechanical Properties of Urogynecologic Implant Materials,Int. Urogynecol. J. (2003) 14: 239-243; and Iglesia et al., The Use ofMesh in Gynecologic Surgery, Int. Urogynecol. J. (1997) 8:105-115.

Possible non-synthetic materials include allografts, homografts,heterografts, autologous tissues, cadaveric fascia and fascia lata.

Surgical Methods

In another aspect, the present invention comprises a surgical method,e.g. for prolapse repair. FIG. 7 shows a prolapsed vagina V and a femalepelvis with obturator foramen O.

FIGS. 9 through 22 illustrate one example of a surgical procedure fortreating prolapse. The goal of the procedure is to perform a vaginalvault suspension using an implant fixed relative to the vagina (e.g. onor near the vaginal apex). FIG. 8 shows surgical instruments 10 and 20and implant assembly 30 that are conveniently assembled for purposes ofconducting the subsequent surgery. The surgical instruments 10 and 20and implant assembly 30 may optionally be packaged together and openedjust prior to the procedure. The implant assembly 30 preferably includesan implantable surgical mesh 34, a separable insertion sleeve 32 and apair of dilating connectors 35.

For fitting the implant 34, at least two routes are possible: one withan anterior dissection and one with posterior dissection. This procedurecan be conducted after previous or concomitant hysterectomy and in casesof uterus preservation. Preferably, specific instruments 10 and 20 arepassed through the membrane OM in the region of the obturator foramen Oto place the implant 34. The implant 34 stabilizes the vaginal vault byfixation on both sides through, e.g, pelvic muscles and membranes.

Posterior Route Fixation:

The posterior vaginal wall is incised longitudinally from the apex APdown to the perineum incision. (Lowest part incision may be done forposterior myorraphy). The rectum is dissected from the vaginal wall,preferably substantially the entire portion. The para-rectal space isopened in both sides with dissection deeply to the ischial spines IS.The index finger of the surgeon can palpate levator ani and deeper, theischial spine IS.

FIG. 9 schematically illustrates a preferred needle passage. The needlepassage is preferably through the inferior part of the obturatormembrane O in the region of the obturator foramen above the ischio-pubicramus. After a small skin incision, the distal end portion 15 of theinstrument 10 is pushed through the obturator membrane O. As shown inFIG. 10, the distal end portion 15 is moved initially toward the regionof the patient's ischial spine IS. The surgeon's index finger canpalpate the needle tip through the muscular wall going to the ischialspine IS. The distal end 15 of the instrument is pushing out through thelevator ani when it arrives at the level of the spine. FIG. 11 shows thesurgeon's finger palpating the distal end 15 of the needle. FIG. 12shows the arrangement after the distal end portion of the needle afterit has passed through a vaginal incision I.

In FIG. 13, the surgeon moves the dilating connector 35 of the implantassembly 30 toward the end portion 15 of the needle. The dilatingconnector 35 is then connected to the needle tip (FIG. 14). This isshown taking place within the vaginal region. Preparation for this stepis shown in FIG. 13. As shown in FIGS. 15 and 16, the needle 12 ispulled back out obturator O and the implant assembly 30 is essentiallyin place on one side of the patient. FIG. 17 illustrates a scissors Safter it has separated the surgical instrument 10 and dilating connector35 from the remaining portion of the implant assembly 30.

As shown in FIGS. 18, 19 and 20, the same procedure is accomplished onthe opposite side of the patient with the opposite end of the implantassembly 30.

As shown in FIG. 20A, the implant 34 may be fixed to the vaginal wallwith two stitches 101 about 1.5 cm from the apex AP. It can also befixed to the rectum (e.g. in the region or directly to) with two otherstitches. The implant 34 is between the vagina and rectum. Its passagethrough the levator ani is on both sides, the fixation point of thevaginal vault suspension.

Once the implant 34 is implanted, the insertion sheaths 32 may beremoved as shown in FIG. 21. FIG. 22 shows the corrected prolapse withthe vagina V supported by implant 34.

The posterior repair can be accomplished with posteriorperineo-myorraphy and some times plications of the rectal fascia. Thevaginal wall may be closed with a suture from the vaginal apex to thelowest region of the perineum.

Anterior Route Fixation:

The stabilization of the vaginal vault can also be accomplished with ananterior route (e.g. if the surgeon prefers this route for surgicalreasons). The implant 34 may be implanted by anterior dissection of theanterior vaginal wall. The bladder is dissected off the vagina. Thepara-vesical space is opened on both sides going to the ischial spinesIS.

The needles 10 and 20 may be used similarly in the posterior procedureand the implant can be fit through muscular wall in both sides. Theimplant 34 may be fixed to the anterior part of the vaginal vault at theapex AP.

All patents, patent applications, journal articles and publicationsmentioned herein are expressly incorporated by reference in theirentirety.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

1. A surgical instrument for inserting an implant for treating femaleprolapse, the surgical instrument comprising: a handle; a needle portionhaving a straight portion emerging from the handle and a generallyhelical portion having a distal end region, wherein the needle portionis sized and shaped so that the distal end region may initially be movedthrough a patient's obturator foramen toward the region of the patient'sischial spine, and then toward a vaginal incision in the region of thevaginal apex, so that an implant may be received by the distal end ofthe needle and moved from the vaginal incision through the patient'sobturator foramen.
 2. A surgical instrument according to claim 1 whereinthe generally helical portion comprises a left handed helical portion.3. A surgical instrument according to claim 1 wherein the generallyhelical portion comprises a right handed helical portion.
 4. A surgicalinstrument according to claim 1 wherein the needle portion has agenerally circular cross section with a diameter of less than about 5.5mm and more than about 0.5 mm.
 5. A surgical instrument according toclaim 1 wherein the straight portion of the instrument has alongitudinal axis and the helical portion has a length, measured alongthe longitudinal axis of the straight portion, of more than 2 inches andless than twelve inches.
 6. A surgical instrument according to claim 1wherein the helical portion has a width of more than about 1 inch andless than about nine inches.
 7. A surgical instrument according to claim6 wherein the helical portion has a pitch of at least 2 inches and aradius of at least 0.5 inches.
 8. A surgical instrument according toclaim 1 wherein the straight portion of the instrument has alongitudinal axis and the helical portion has an axis that is notparallel to the axis of the straight portion.
 9. A surgical instrumentaccording to claim 8 wherein the axis of the straight portion and theaxis of the helical portion form an angle of about 8 degrees.
 10. Asurgical instrument according to claim 8 wherein the distal end portionof the instrument points away from the handle and at an acute anglerelative to a plane that is perpendicular to the longitudinal axis ofthe straight portion of the instrument.
 11. An assembly of surgicalinstruments for treating female prolapse, the assembly comprising: afirst surgical instrument comprising a handle; a needle portion having astraight portion emerging from the handle and a generally right handedhelical portion having a distal end region, wherein the needle portionis sized and shaped so that the distal end region may initially be movedthrough a patient's obturator foramen toward the region of the patient'sischial spine, and then toward a vaginal incision in the region of thevaginal apex; a second surgical instrument comprising a handle; a needleportion having a straight portion emerging from the handle and agenerally left handed helical portion having a distal end region,wherein the needle portion is sized and shaped so that the distal endregion may initially be moved through a patient's obturator foramentoward the region of the patient's ischial spine, and then toward avaginal incision in the region of the vaginal apex; and an implant fortreating the prolapse.
 12. An assembly of surgical instruments accordingto claim 11 further including a pair of dilating connectors andinsertion sleeves surrounding the implant.
 13. A surgical procedure forcorrecting human vaginal prolapse comprising: providing a first surgicalinstrument comprising a handle; a needle portion having a straightportion emerging from the handle and a generally right handed helicalportion having a distal end region; a second surgical instrumentcomprising a handle; a needle portion having a straight portion emergingfrom the handle and a generally left handed helical portion having adistal end region; creating a vaginal incision; incising the patient'sskin in the region of the patient's obturator foramen on a first side ofthe patient, passing the distal end portion of the first surgicalinstrument through the obturator foramen and then through the vaginalincision; associating the implant with the first surgical instrument;incising the patient's skin in the region of the patient's obturatorforamen on a second side of the patient, passing the distal end portionof the second surgical instrument through the obturator foramen and thenthrough the vaginal incision; associating the implant with the secondsurgical instrument; moving the distal end portion of the first surgicalinstrument from the vaginal incision through the patient's obturatorforamen with an end of the implant associated with the distal endportion; moving the distal end portion of the second surgical instrumentfrom the vaginal incision through the patient's obturator foramen withan end of the implant associated with the distal end portion; andattaching the implant to the vagina.
 14. A method according to claim 13wherein the step of creating a vaginal incision includes the step ofcreating a vaginal incision in a region of the apex of the vagina.
 15. Amethod according to claim 13 wherein the step of passing the distal endportion of the first surgical instrument through the obturator foramenand then through the vaginal incision includes the step of passing thedistal end of the instrument through the inferior part of the obturatormembrane in the region of the obturator foramen above the ischio-pubicramus.